· web viewdistributions based on study type and cost analysis of the final selected literature...

Appendix 1: Flowchart of search results.

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Appendix 2: Quality of selected literature and data analysis

Distributions based on study type and cost analysis of the final selected literature are represented in figures A2.1 and A2.2, respectively. Observational studies, both prospective and retrospective dominate the study spectra (figure 2), with various approaches to cost analysis (figure A2.2).

Figure A2.1. Number of publications per study type.

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Figure A2.2. Number of publications per cost analysis.

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A continuously increasing number of research reports about POCT and its cost effectiveness was observed over the last 20 years. These reports were dominantly originating from studies undertaken in United States, followed by Sub-Saharan Africa region (figure A2.3). The main health concern examined within the studies were related to maternal and child care, followed by cardiovascular diseases (figure A2.4).

Figure A2.3. Number of publications per region/country.

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Figure A2.4. Number of publications per disease type.

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Studies can also be classified as a function of the country’s income level as grouped by the World Bank. Most of the literature belongs to studies undertaken in high income group countries (figure A2.5).

Figure A2.5. Number of publications per country’s income group.

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Table A3.1. Summary of the selected literature on POCT in maternal and neonatal care based on type of POCT.

Author/Year

Type of study / country

Study design/ Sample size

Disease/ Target Population

Health Outcomes Economic Outcomes Comments

Ultrasound (POCUS) including US training

Amoah et al. 201625

Pilot study

Ghana (Central region)

Survey preceding roll out of pilot ANC system: 100 women (aged between 19 and 49, mean = 29.4 ± 6.5 years, had pregnancies within 5 years prior to the study) were interviewed in the preliminary survey

The pilot project: 323 pregnant women from four rural communities in the Central Region of Ghana were followed within a 11-month project

40 gave birth during observation

Maternal and child death, obstetric complications

Pregnant women in rural communities in low income countries

Preliminary survey: Women had their births attended by skilled attendants - less likely to have retained placenta (p<0.05);Women attended ANC - less likely to have a miscarriage (p<0.001); Women attended at least four ANC visits - less likely to practice self-medication (p<0.05)Pilot Study:40 gave birth during observation: 62.5 % of pregnant women had their labor attended in clinics or hospitals as against 37.5 % among the cases reported in the pre-survey. 1 case of ectopic and 2 cases of breech pregnancies were detected, and appropriate medical interventions were sought.

Promising results were shown by using an application for low-cost mobile phones and portable ultrasound machines, by offering professional monitoring and supervision in rural areas.

Allow early detection of specific adversities, which reduces the time between first appearance andprofessional care.

Community initiative, an onlinemanagement system

A remote ultrasound imaging approach combining CHWs and portable ultrasound acquisitions.

WHO has recommended at least 4 ANC visits and skilled attendants at birth.

A comprehensive cost-benefit analysis needs to be carried out.

Chan et al. 200124

A pilot study

71 patients with a total of 90 tele-ultrasound consultations

Fetal anomaly 90% of the babies have been delivered, and outcome data have been received on all pregnancies.All significant anomalies and diagnoses

A crude cost–benefit calculation suggests that the tele-ultrasound service resulted in a net

Realtime fetal tele-ultrasound consultation service:uses ISDN transmission at

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with cost benefit analysis

Queensland, Australia

have been confirmed.Major indications for referral were: complex fetal problems such as twin complications or multiple fetalanomalies (43%); detailed assessment of high-risk patients (19%); isolated fetal anomalies (17%); evaluation of markers for anomalies (13%); and assessment of growth restriction/ fetal wellbeing in the third trimester (8%).The referring clinicians would have physically referred 24 of the 71 patients to Brisbane in the absence of telemedicine.

saving of A$6340, enabling almost 4 times the number of consultations to be carried out.

384 kbit/s, allows patients in Townsville to be examined by subspecialists in Brisbane, 1500 km away.

Only crude estimates. Neither the initial set-up and equipment costs nor the costs for the clinicians have been included. Benefits in terms of reduced anxiety and social costs to the families involved were not measured.

Crispín Milart et al. 201614

Observational case-control study

Guatemala (rural)

From September 2012 to November 2013, the community facilitators attended a total of 1,509 pregnant women.

Control group is composed by 747 pregnant women attended by the community facilitator, which is the common practice in rural Guatemala.

Intervention group is composed by 762 pregnant women

Maternal and neonatal mortality

No maternal deaths reported within the intervention group vs 5 cases in the control group.64% reduction of neonatal mortality. 37% prevalence of anemia detected. 42 cases (5.5%) with hemoglobin levelsunder 9 g/dL.Diagnosis and treatment of anaemic patients would have been useful for the prevention of 2 death cases due to postpartum haemorrhage.633 results of urine dipsticks were reported; urinary tract infection was diagnosed and treated in 29 cases (4.58%). 1 patient was referred by positive proteinuria and suspected preeclampsia.Non-urgent referral was recommended to 70 pregnancies, the main reported

The major reduction observed in maternal and neonatal mortality provides promising prospects for these low-cost diagnostic procedures.

Portable ultrasound (important diagnostic tool for fetal malpresentation, twinpregnancy, amniotic fluid pathology and abortions)

Blood/urine testsCare package include: screening for anemia, screening for maternal bacteriuria, screening for hypertensive disorders of pregnancy, iron supplementation to prevent maternal anemiaand preparedness for births and emergencies.

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attended under the innovative Healthy Pregnancy project.

cause being fetal malpresentation. Intervention and control groups were not randomly assigned.


Cuneo et al. 20199

Prospective study with cost benefit analysis

United States

455 US-based telecardiology performed for 368 pregnant women from November 2015 to December 2018 (Mean±SD maternal age: 29.6±66.2 years, ranged 16–49 years; Mean gestational age: 25.2±4.4 weeks, ranged 13–39 weeks).

Fetal Cardiac Anomalies

With telecardiology, all foetuses with congenital heart disease (CHD) were correctly risk-stratified for delivery.

CHD or arrhythmia was diagnosed in 28 and 15 foetuses respectively, with 1 false-negative result in CHD.

No mother had to return for a second telecardiology appointment because of poor echocardiographic image quality.

Cost savings per visit for point of care telecardiology were

USD$61 at a local site and USD$581 at a distant site, mainly due to savings in travel and accommodation and in cost of lost work (for a mother travelling for an appointment to a local site)

The feasibility of this service was found to depend

on strong links with the community,

obstetric care providers and the obstetric ultrasonographers.

Telecardiology improved access to subspecialty

care services for a vulnerable population.

Could be a model for expansion to remote and rural communities.

Kozuki et al. 201615

Prospective observational study with cost analysis

Nepal (rural)

Women who were ≥32 weeks in gestational age were enrolled and received ultrasound examinations from the auxiliary nurse midwives during home visits.

Non-cephalic presentation, multiple gestation, and placenta previa

Among the 745 women with true fetal presentation data, 29 were diagnosed with singleton non-cephalic presentation. 10 resulted in a true non-cephalic birth and 3 in Caesarean section. 2 non-cephalic births were identified. Of the 786 women with twinning data, 5 were diagnosed with twins on ultrasound, and all five were true

The total cost of ultrasound machine, gel, and personnel training over five-years would be $10,355, for 15,000 births over five years in a catchment area of 100,000 in population.

POCUSultrasound trainings

Estimated cost of $65 per life saved.

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804 women enrolled multiple births. No twin pair went undiagnosed.Over 5 years, 160 perinatal deaths may be avoided with early diagnosis.

Ross et al. 201312

Retrospective quantitative study - nocontrol group

Uganda (rural)

Records at Nawanyago clinic were reviewed to obtain the number of antenatal visits and deliveries for 42 months preceding the introduction of ultrasound and 23 months following the implementation of POCUS..

General conditions for maternal and neonatal health

Significant increases were seen in the number of mean monthly deliveries and antenatal visits. The mean number of monthly deliveries at the clinic increased by 17 (13.3–20.6,95% CI) from a pre-ultrasound average of 28.4 to a post-ultrasound monthly average of 45.4. The number of deliveries at a clinic used as control remained flat over this time. The monthly mean number of antenatal visits increased by 97.4 (83.3–111.5, 95% CI) from a baseline monthly average of 133.5 to a post-ultrasound monthly mean of 231.0, with increases seen in all categories of antenatal visits.

The availability of a low-cost antenatal ultrasound program may assist progress towards MillenniumDevelopment Goal 5 by encouraging women in a rural environment to come to a health care facility for skilled antenatal care and delivery assistance instead of utilizing more traditional methods.

A Low-Cost Ultrasound Program


Vinayak et al. 201710

Prospective cross-sectional study; pilot study

Cost analysis

A curriculum (training period was just more than 1 month) was designed to teach 3 midwives without previous training in ultrasound to independently work at a healthcare facility to identify high-risk

Care of pregnancy in rural area

Excellent correlation between final outcomes of pregnancies and diagnoses on the basis of reports generated by the midwives.

Scan results versus actual outcomes revealed 2 discrepancies in the 20 patients identified as high risk.

Overall flow turnaround time (from patient presentation to validated report) was reduced from 35 min to 25 min. The unique mobile phone transmission was faultless and there was no degradation of image quality. The cost of the

Training of midwives to perform basic obstetric ultrasoundexaminations in rural area

A tablet-sized ultrasound scanner VISIQ

Identification of high risk

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Kenya pregnancies.Consecutive pregnant patients 18–50 y ofage were recruited to have a scan at 1 of the 3 antenatal clinics, and a total of 271 patients were scanned, 220 patients were tracedto delivery.

internet bundle (1 GB) per 5 patients was approximately $1.00 Valuable to train midwives in POCUS to use an ultrasound tablet device and transmit images and reports via the internet to radiologists for review.

patients through POCUS was valuable in a remote healthcare facility.

Biomarkers / lab test based POCT

Arthurs et al. 201020

Retrospective observationalcost analysis study

United Kingdom

Assessment of laboratory workload by retrospective review of hospital clinical information systems, pathology databases, patient admission rate and clinical workload

Study period: 3 years, including 12 monthsimmediately before and 24 months immediately after the introductionof the Roche OMNI-S analyzer to the neonatal unit.

Neonates

neonatal intensive care units

An increase in the number of admissions(15.7%) and total days of neonatal activity (21.8%). A concurrent decrease in the number of laboratory assays (-38.0%) and transfusions performed over the same time (-18.7%). This equates to a 46.4% reduction in lab testing and a 29.6% reduction in transfusions per admission.

POCT analyzerthe Roche OMNI-S blood gas analyzer

Clear cost-effectiveness was demonstrated through POCT implementation.

El Helali et al. 201950 11,226 deliveries in 2006– 2009, using antenatal culture for polymerase chain

Neonates Intrapartum PCR screening

was associated with a significant decrease in the rate of proven and

With the implementation of intrapartum GBS PCR screening, the yearly cost of delivery and treatment

GBS is the most common pathogen resulting sepsis in newborns during the first week of life in developed

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Observational study

With effectiveness and costs analysis

France

reaction (PCR)

screening for early onset of Group B

Streptococcus (GBS)

and 18,835 deliveries in 2010–2015 with intrapartum PCR screening were recorded.

probable early-onset neonatal GBS disease cases (compared

to antenatal culture screening).

There was a threefold reduction in the total numbers of days of hospital and antibiotics for early onset GBS disease.

of newborns with GBS infection was decreased from USD$41,875±6,823 to USD$11,945±10,303 (P<0.001).

While the intrapartum PCR screening is more expensive (USD$90) compared to antenatal (USD$21) – overall healthcare costs due to early-onset GBS disease

cases/year are reduced.

countries

Point-of-care intrapartum GBS PCR

screening was also associated with a significant decrease in

the rate of early-onset GBS disease and antibiotic use in

newborns.

Golden et al. 201019

Retrospective observational study with cost benefit analysis

United States

Patients undergoing CCduring the first quarter of 2007 (n = 38), with the central laboratory, and patients undergoing CC during the first quarter of 2008 (n = 50), after implementation of a POC blood gas analyzer, were included in the study.

Pediatric patients With the implementation of intrapartum GBS PCR screnning, the rate of proven early-onset GBS disease cases was reduced from 1.01/1,000 to 0.21/1,000 (P=0.026); the rate of probable early-onset GBS disease cases was reduced from 2.8/1,000 to 0.73/1,000 (P<0.001); the total days of hospital and antibiotic therapy for early-onset GBS disease was reduced by 64% and 60% respectively.

The incremental cost of POCT was estimated to be $33 per test, which is very small compared with the overall costs of a CC procedure.

POCT analyzer for ABGs during CC(Radiometer ABL80 analyzer)

Subjective determinations of improved patient caremay be sufficient to justify the increased costs of POCT.

Kovacs et al. 201723

Longitudinal comparison study

Cost-minimization

Costs of bedside DRI-based screening were compared to those of traditional transport and BIO-based

ROP in premature newborns

DRI combined with remote interpretation has similar diagnostic performance to that of BIO.

Meanwhile, bedside ROP screening is

From 2009 to 2014, PCA-PERP saved 92,248 km and 3633 staff working hours, with an annual nominal cost-savings

PCA-PERP: DRI with remote interpretation in bedside ROP screening

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analysis

Hungary

screening.

From 2009-2014, 3722 bedside examinations were performed in thePCA covered central region of Hungary.

needed in vulnerable premature infants and avoidance of transportation.

ranging from 17,435 to 35,140 Euro. The net present value was 127,847 Euro at the end of 2014, with a payback period of 4.1 years and an internal rate of return of 20.8%.

Service provider (PCA) perspective

Mahieu et al 201221

Retrospective observational cohort study

Cost–benefit analysis

Belgium

A study in a NICU compared with two serial cohorts of 2 years each, over a 4-year period (2006–2009)

Data from the 1st cohort (no use POCT, during 2006–2007) were compared with those from the 2nd cohort (after the use of the multi-parameter POCT during 2008–2009)

Throughout the 4-year study period, 1393 patients were enrolled

Very low birth weight infantsiatrogenic blood loss and anemia in NICU patients.

Implementation of POCT decreased central laboratory performed testing for bilirubin (−32% per patient) and electrolytes (−36% perpatient).

On average, the net blood volume taken per admitted patient for electrolyte testing decreased with 23.7% and 22.2% for bilirubin testing in the second cohort. Fewer very low birth weight infants required blood transfusion (38.9% vs 50%, p<0.05) as the number of transfusion/infantsdecreased by 48% (1.57 vs 2.53, p<0.01).

For the entire study population, the cumulative cost for blood transfusion decreased from 35,318€ in the 1st cohort to 29,543€ in the 2nd cohort (−16%) or a saving of 5775€, which is equal to a mean cost reduction of 52.1€ to 41.03€ per neonate (−21%). In the very low birth weight group, the transfusion cost decreased by 7561€ (−24%), from 30,257€ in the first cohort to22,696€ in the second cohort, which represents a mean cost reduction from 44.7€ to 31.7€ per neonate (−29.1%).

Multi-parameter Point-of-Care-blood test analyzer:reduces central laboratory testing and need for blood transfusions

The implementation of POCT was cost-efficient for the Belgian national health insurance, with cost reduction of −8.3% per neonate.

Whitney et al. 201622 A decision analysis model was constructed

Dehydration, common in children

POCT helps evaluate degree of dehydration in children.

From the perspective of the payer, POCT resulted

POC electrolyte testingi-Stat Analyzer, a handheld,

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Randomized control trial

Cost-effectiveness analysis

United States

to calculate cost-savings from the point of view of the payer and the provider.

with AGE in PED in a cost savings of $303.30 per patient compared to traditional serum testing.From the perspective of the provider, POCT resulted in mean savings of $36.32 ($8.29-$64.35) per patient.

cartridge-driven device capableof performing basic electrolyte and blood gas tests in less than 2minutes, with less than 0.1 mL of blood.

Hospital perspective

Models of care

Gao et al. 201417

Prospective cohort study (retrospective baseline data)

A cost-consequences analysis

Northern Territory, Australia

Compare the cost-effectiveness of 2 models of service delivery: MGP and baseline cohortBaseline cohort (retrospectively audited) included all Aboriginal mothers (n=412), and their infants (n=416), from 2 remote communities who gave birth between 2004 and 2006. The MGP cohort (prospective) included all Aboriginalmothers (n=310), and their infants (n=315), from 7 communities who gave birth between 2009 and

Care of pregnancyin Aboriginal mothers and infants

MGP: women had significantly more antenatal care, more ultrasounds, morelikely to be admitted to hospital antenatally, and had more postnatal care in town (2.5 vs 1.6, p<0.001); had significantly reduced average length of stay for infants admitted to SCN.

MGP women experienced better outcomes associated with vaginal birth than women in the baseline cohort (p<0.001) but there was no difference with caesarean birth (p=0.757).No significant difference between the two cohorts for major birth outcomes such as mode of birth, preterm birth rate and low birth weight.

Costs savings of MGP (mean AUD 703) were found, although these were not statistically significant, compared to the baseline cohort.MGP: significantly reduced birthing costs (− AUD 411, p=0.049) and SCN costs (− AUD 1767, p=0.144) but increased costs of antenatal care (AUD 272, p<0.001), postnatal care in town (AUD 277, p<0.001), infantread mission costs (AUD 476, p=0.05) and travel (AUD 115, p=0.011)For remote dwelling Aboriginal women of all risk who travelled to town for birth, MGP was

MGP: characterised by a small group of midwives (3–4) offering continuity of care throughout pregnancy, labour, birth and the early postnatal period.MGP team provided a woman-centred model of care to all remote dwelling women, from 7 communities who were transferred to Darwin for birth

Team was based in a suburban shopping complex 3km away from the hospital.

Department of Health perspective.

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2011. likely to be cost effective.

Archibong et al. 201718

Analytical study

United States

Tests for the function of the platform

Pregnancy-related complications

Preeclampsia and HELLP syndrome

Provides potential life-saving advantage with a turnaround time of about 10min (vs over 4 hours for conventional laboratory analytical methods)Haemoglobin concentrations can be measured with an accuracy of ~1mg/dL at lower hemoglobin values

Primary cost of the platform is the smart phone.Provides potential life-saving advantage with a cost of circa $1/ unit (assuming with the presence of phone and software).

POC mobile phone–based platform (mHealth platform): quickly characterise level of hemolysis by measuring the color of blood plasma


Abbreviations: ANC = antenatal care; CHWs = Community health workers; HELLP = hemolysis, elevated liver enzymes, and low platelet count; POC = Point-of-care; POCT = point-of-care testing; MGP = Midwifery Group Practice; SCN = Special Care Nursery; ABGs = arterial blood gases; CC = cardiac catheterization; DRI = digital retinal imaging; PCA-PERP = Peter Cerny Ambulance - Premature Eye Rescue Program; BIO = binocular indirect ophthalmoscopy; ROP = retinopathy of prematurity; NICU = neonatal intensive care unit; AGE = Acute gastroenteritis; PED = pediatric emergency department.

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Table A3.2. Summary of the selected literature on POCT in cardiovascular disease based on type of POCT.

Author/Year

Type of study / country

Study design/ Sample size Disease/ Target Population


Ultrasound (POCUS) and Echocardiography

Ferrada et al. 201431

Retospective study

Cost analysis

United States

Evaluate the utilityof LTTE in nonsurviving patients who presented to the trauma bay with traumatic cardiac arrest.(patients undergoing LTTE vs non-LTTE).From Jan 2012 to Jan 2013, 37 patients did not survive traumatic cardiac arrest while in the trauma bay: 14 in the LTTE group and 23 in the non–LTTE group.

Patientswith Traumatic Cardiac Arrest

Decreases the rate of nontherapeutic interventions

Compared with the non–LTTE group, the LTTE group spent significantly less time in the trauma bay (13.7 vs 37.9 min), received fewer blood products (7.1% vs 31.2%), and were less likely to undergo nontherapeutic thoracotomy in the emergency department (7.14% vs 39.1%; P < 0.05).

The non–LTTE group had a mean of $3040.50 in hospital costs, compared with the mean for the LTTE group of $1871.60 (P = 0.0054).

The mean hospital charges for LTTE were $8282.50, which were statistically significantly lower compared with $14,182.30 for the non–LTTE group (P = 0.0135).

Limited transthoracic echocardiography (LTTE) is cost efficient in trauma bays.

Hothi et al 201429

Descriptive study

United States

Evaluation of applications, advantages and limitations of devolved quick-scancardiac ultrasound by H-USS.

Cardiac diseases A quick-scan is rapid (3-5 min) and can quickly identify pericardial effusion, severe LV systolic dysfunction (LVSD), RV dilatation, major heart valve disease and inferior vena cava (IVC) dilatation, allowing immediate potentially lifesaving

H-USS devices cost around £5,000 are portable and ideal for integration with clinical examination, compared to complex devices (£100,000) and more classic portable machines (£30,000–£40,000) (often battery

Quick-scan cardiac ultrasound by H-USS.


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changes in management. Inferior at assessing LV dimensions, RV function and mitral regurgitation, and cannot assess diastolic function.

powered, enabling movement between beds without being turned off).

Ploutz et al. 201638

Prospective study

Uganda, Gulu

1002 children were enrolled, with956 (11.1 years, 41.8% male) having complete data for review.

Conducted between June and August of 2014 in 2 public primary schools to evaluate the performance of a simplified screening approach in the hands ofnon-experts.

RHD 913 (95.5%) children wereclassified normal, 32 (3.3%) borderline RHD and 11 (1.2%) definite RHD.

The simplified approach had asensitivity of 74.4% (58.8% to 86.5%) and a specificity of 78.8% (76.0% to 81.4%) for any RHD (borderline and definite). Sensitivity improved to 90.9% (58.7% to 98.5%) for definite RHD. Identification / measurement of erroneous colour jets was the most common reason for false-positive studies (n=164/194), while missed mitral regurgitation and shorter regurgitant jet lengths with HAND were common reasons for false negative studies (n=10/11).

Offer a potential solution to financial and workforce barriers that limit widespread RHD screening.

Compared with STAND, HAND offers a lower price point and higher degree of portability. Length of encounter was 6.69 min (SD 2.54 min) with 4.97 min (SD 2.28 min) required to acquire theechocardiographic images.

Handheld echocardiographyNon-expert-led HAND screeningprograms


Biomarkers / lab test based POCT

Apple et al. 200633 Patients presenting with symptoms suggestive of ACS were enrolled pre-POC (PreCS, n=271) and post-

ACS patients in a community hospital cardiology unit, e.g. AMI

One-year survival was greater in the <0.1 μg/l patients (PreCS 96.2%, PostCS 97.2%) compared to the ≥0.1 μg/l patients (PreCS

A decrease in time from blood draw to result for the healthcare provider (PreCS mean 76 min; PostCS mean 19.5 min; p<0.001)

POC cardiac troponin I (cTnI) testing

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Observational retrospective study

Cost consequence analysis

United States

POC (PostCS, n=274).Both short stay and intensive care patients

77.7%, PostCS 75.5%); both p<0.001.

In the PreCS group there were 6 deaths in the <0.1 μg/l cTnI group (n=195) compared to 12 deaths in the ≥0.1 μg/l cTnI group (n=76).

In the PostCS groups, there were 6 deaths in the <0.1 μg/l cTnI group (n=250) compared to 4 deaths in the ≥0.1 μg/l cTnI group (n=24).

A decrease trend in charge per patient admission ($4281 savings) following of POC testing. Total charges per patient admission decreased by 25% PostCS vs. PreCS ($17,163 vs. $12,882); lower charges for: boarding (−21%), other departments (−58%), pharmacy (−28%), labs (−22%), non-cardiac procedures (−28%), cardiac procedures (−14%). Mean LOS decreased from PreCS (2.36 days) to PostCS (2.19 days).cTnI reagents charges to the lab were higher for POC assay, $10.54 vs the central lab assay, $3.83.

Overall, POC for cardiac troponin testing showed cost-effectiveness.

Blick 200532

Prospective study

Cost analysis

United States

Around 4200 patients with chest pain annually were evaluated in the study

Data mining for outcomes was performed on the Meditech computer system

Peer comparison data were acquired from Healthcare Corporation of America and Cardiac Data Solutions

ACS and CHF No reported inapt discharge-to-home events.

A reduction in 15 hours ED LOS/wait time for ACS workup of non-ST-segment elevation acute myocardial infarction patients to a consistent ED LOS of no more than 8 hours. Due to rapid (< 2h) POC testing protocol, the time to discharge for ED chest pain patients was reduced from 3.6 to 2.3 hours. Inpatient LOS for CCU CHF patients has been significantly reduced from 5.2 to 3.2 days, a potential savings of over $1000

POCT for cardiac markers, includemyoglobin, CK-MB, and troponin I, for ACS evaluation and BNP for CHF evaluation

POCT for cardiac markers justified by positive health economics parameters

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per day per patient, with an estimated total savings of 440 CCU patient-days in this setting.

Fitzgerald et al. 201134

Randomized controlled trial

Cost utility analysis

United Kingdom

RATPAC trial -multicenter randomized controlled trial comparing rapid diagnostic assessment with a POC biomarker panel to standard care

Patients attending 6 EDswith acute chest pain due to suspected MI (n = 2,243)Standard care, n = 1,118; POC, n = 1,125.Cost-effectiveness was estimated in terms of probability of dominance and incremental costper QALY.Data were collected from 246 patients for the micro-costing study.

Chest pain due to suspected MI

Mean QALYs in POCT were 0.158 (SD ± 0.052) vs 0.161 in standard care (SD ± 0.056; p = 0.250)

Greater use of coronary care and cardiac interventions is appropriate and confers patient benefit. However, this benefit is uncertain and difficult to estimate in thislow-risk patient group.

Overall, the micro-costing study showed that POC testing added £53.16 ($82.87) to the costs of ED management.

Point-of-care panel assessment was associated with higher ED costs, coronary care costs, andcardiac intervention costs, but lower general inpatient costs.Mean costs per patient were £1217.14 (SD ± £3164.93), or $1,987.14 (SD ± $4,939.25), with POC vs £1005.91 (SD ± £1907.55), or $1,568.64 (SD ± $2,975.78), with standard care (p = 0.056).

Point-of-care panel assessment was not shown to represent a cost-effective use of health care resources.

Point-of-care biomarkerassessment for suspected MI

Biomarkers included CK-MB, myoglobin and troponin

United Kingdom National Health Service's perspective

Spalding et al. 200730

Retrospective study

Cost consequence analysis

Annual treatment costs of all cardiosurgical patients were analyzed before (729 patients) andafter (693 patients) implementation of ‘bedside’ coagulation test

Perioperative coagulation management in cardiac surgery

Total number of resternotomies decreased from 6.6% to 5.5% without reaching statistical significance (p = 0.384) while early mortality (5.9%; 6.0%) remained stable.

After POCT implementation, cumulative RBC expenditure showed 25% decrease while PltCexhibited 50% decrease. FFP expenditure remained unchanged. PCC, FXIII factor concentrates were markedly reduced (-80%). Fibrinogen,

‘Bedside’ coagulation test

Saved costs for blood- and coagulation products noticeably outweighed the expenses of POCT.

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Germany

Average monthly numbers and costs were compared. Number of resternotomies and early mortality was assessed and compared in both periods.

however, increased two-fold. Cumulative average monthly costs of all blood products decreased from 66,000€ to 45,000€ (-32%).Coagulation factor average monthly costs decreased from 60,000€ to 30,000€.In contrast, average monthly costs for POCT were 1.580€.Overall, costs decreased from €125,828 to €55,925.

Adequate differential coagulation management can be cost-effective.

Models of care

Tirimacco et al 200928

Prospective study

South Australia (rural)

Analysis of patient outcome via Integrated South Australian (SA) Activity Collection inpatient separations database that collects patient demographics, primary and secondary diagnoses, procedure codes, nature of separation / admission, discharge date. Analysis of effectiveness: previous South East Regional Health Service as the intervention site,compared to other rural sites in SA with noinvolvement in the Network as controls.

ACS Preliminary results showed improved patient outcomes in the Network by significantly reducing the 30-day readmission rate for ACS from 10.4% to 4.2% (P = 0.03).

A marked trend to reduction of ACS in hospital death rates from 15.8 to 9.8%.

Significant potential cost savings for hospitals involved in the Network have been identified: reduced unnecessary patient transfers, improved bed capacity from POCT availability in smaller hospitals, reduced urgent specimen transport and laboratory staff recall costs, a reduction in the 30-day readmission rate for ACS and improved patient clinical outcomes including reduced in-hospital ACS death rate.

iCARnet/ Network based on POC pathological testing for troponin.

Troponin POCT protocols were integrated with treatment and triage recommendations in clinical pathways for chest pain and ACS management


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Abbreviations: AMI = acute myocardial infarction; ACS = acute coronary syndrome; POC T= point-of-care testing; LOS =length of stay; CHF = congestive heart failure; ED = emergency department; BNP = B-type natriuretic peptide; CCU = coronary care unit; LTTE = Limited transthoracic echocardiography; MI = myocardial infarction; H-USS = hand-held ultrasound; HAND = Handheld echocardiography; RHD = rheumatic heart disease; STAND = standard portable echocardiography; RBC = red blood cell; FFP = fresh frozen plasma; PltC = Platelet concentrates; iCARnet = Integrated Cardiac Assessment Regional Network.

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Table A3.3. Summary of the selected literature on POCT in general clinical diagnosis

Author/Year

Type of study

Study design/ Sample size Disease/ Target

Population

Types of POCT


Barron et al. 201836

Observational prospective study

Nicaragua, Sébaco, (rural)

A total of 79 POCUS examinations were performed on 59 patients by 2 physicians with extensive POCUS training during a 1-week-long medical mission in Feb 2017.80% were women, withan average age of 40.5 years (range 1.6–87 years).Determine how oftenPOCUS changed medical management. Assess the most commonreasons for POCUS use.

General clinical diagnosis

POCUS The use of US changed management for 35.6% of total patients examined, divided among: changes in diagnosis, pharmacotherapy, new referral, or referral not needed.

A wide range of POCUS examinations were performed, with lung, gallbladder, obstetric/gynecologic, and cardiac examinations performed most often.

The average time to perform a POCUS examinationwas 6.0 minutes. POCUS was used to add value to patient care, reduce referrals, thus costs of healthcare delivery in RLSs

An increased interest in nonemergency and noncritical care POCUS was seen, with increase of low-cost, accurate, handheld US devices. It is probable that more physicians traveling to RLSs will use POCUS positively affecting patient care.


Blattner et al. 201039

Prospectivecost analysis

New Zealand (remote north).

Test indication, pre-test differential diagnosis and planned patient disposition were recorded over 6 months before and after POC test use in November 2008

269 POC tests were undertaken for 177


POCTs in a rural hospital

POCTs significantly increased diagnostic certainty (2.5 diagnoses pre-test vs 1.3 diagnoses post-test (p<0.001)), and altered disposition for 43% of patients (p<0.001) by reducing transfers to base hospital by 62% and increasing discharges by 480%.SIgnificant treatment change

Overall financial benefits amounted to $452,360 annually.

POCT can improve diagnostic accuracy in a cost-effective manner.

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patients. was reported in 75% of cases.

Laurence et al 201040

Randomisedcontrolled trial

Cost-effectiveness analysis

Australia

A total of 4968 patients were recruited: 3010 (intervention group) and 1958 (control group).All patients were followed up for 18 months by 53 general practices in urban, rural and remote locations across three states in Australia.Assess the incremental cost effectivenessof a clinical strategy based on performing POCT in GP compared to current practice of testing through a pathology laboratory.


Point of care testing in ageneral practice setting

All POCT resulted in an increasein the number of tests per person-year.

Higher number of GP visits per person-year for the intervention group (19.2 visits) compared to the control group (13.6 visits)

Total direct costs per patient to the health care sector for POCT was less for ACR (-$34) than pathology lab testing, but greater for INR, HbA1c and lipids, although none of these was statistically significant.

There was no statistically significant difference in overall costs between point of care and lab, irrespective of tests.

For all tests, the intervention group had significantlylower patient costs for travel and time seeking healthcare.

Australian society overall's perspective

Nnakenyi et al. 201752

Descriptive study

Nigeria

A descriptive study of 61 POCT sites at 5 tertiary hospitals across Nigeria


A wide range of POCT devices tested

59% of sites used POCT because of rapid result with all tests. They included: glucose meters, Urinalysis dipstick, HIV rapid test, hematocrit reader, urine pregnancy test, HbA1c, malaria rapid test, cholesterol/ lipid profile, coagulometer, blood gas analyzer, bilirubin meter, cardiac marker reader, urea/ creatinine, HBsAg rapid kit, Hepatitis C virus rapid kit, syphilis rapid test and Urine drug abuse test.

POCT costs below $2 in 54% of the sites. Results are produced in less than 5 minutes and require blood specimens ranging from a drop to 3 mL, whereas urine-based tests need 5 to 20 mL.

Several POCT devices can be efficiently implemented in remote areas.

Reynolds et Data on POCUS studies during a period of 10

General clinical POCUS Use of POCUS changed either diagnostic impression or

N/A Use of POCUS for health benefits is

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al. 201835

Prospective descriptive cross-sectional study

Tanzania,

Dar es Salaam

months was collected on consecutive patients during periods when research assistants were available.Data was collected for 986 studies performed on 784 patients. Median patient age was 32 years; 56% were male.

diagnosis disposition plan in 29% of all cases.

Rates of change in diagnostic impression or disposition plan increased to 45% in patients for whom more than one POCUS study type was performed

justified in general clinical settings.

Cost-benefit analysis needs to be carried out.

Rominger et al 201837

Descriptive study

Mexico, state of Chiapas

584 ultrasound studies were documented over 12-month period.


POCUS 12-month longitudinal ultrasound educational curriculum

Most common investigations: transabdominal obstetric examination (45.5%), abdomen/pelvis (26.6%), musculoskeletal (5.7%), skin and soft tissue (5.7%). POCUS changed the clinical diagnosis in 34% of patients and likely prevented delays in care and expedited referral and hospitalization where needed.

The longitudinal study was an efficient way to teach ultrasound in resource limited settings. If offers local physicians with a tool to guide clinical diagnoses and improve patient management.


Spaeth et al. 20182

Retrospective study with cost effectiveness analysis

Australia, Northern

A decision analytic simulation model used to assess whether POCT leads to cost savings compared to usual care in three separate acute medical conditions.

3 common acute conditions (chest pain, chronic renal failure due to missed dialysis session(s), and acute diarrhea

POCT included tests for cardiac troponin I, electrolytes, blood gases, urea, creatinine, glucose, ionized

POCT prevented 60 unnecessary medical evacuations from a total of 200 patient casesmeeting the selection criteria (48/147 for chest pain, 10/28 for missed dialysis, and 2/25 for acute diarrhea).

Test results were available in less than 10 minutes.

The associated cost savings for chest pain, missed dialysis, and acute diarrhea were AUD $4,674, $8,034, and $786 per patient translating to NT-wide savings of AUD $13.72 million, $6.45 million, and $1.57 million per annum (AUD $21.75 million in total), respectively.

Health sector (Medicare) cost's perspective.

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Territory (NT) calcium, INR.

Abbreviations: POCUS = point of care ultrasound; US = ultrasound; STMM = Short-Term Medical Mission; RLSs = resource-limited settings; GP = general practice; POCT = point-of-care testing; INR = internationalised normalised ratio; HbA1c = glycated hemoglobin; ACR = albumin creatinine ratio;

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